# K033959: LPS

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jul 1, 2004 after 192 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K870730 (1987). 10 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003182: Orthogenesis LPS System, Depuy, Inc. (2001) Summary page 1.
- K870730: Noiles Total Knee Prosthesis, Joint Medical Products Corp. (1987) Summary page 2.
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 2.

## Most influential descendants
- K233980: ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (2024), 0 descendants of its own
- K063686: Depuy LPS Distal Femoral Component (2007), 0 descendants of its own
- K062301: Depuy LPS Proximal Tibial Component (2006), 0 descendants of its own

## Indications for use
The LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: * malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; * patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; * revision cases for a failed previous prosthesis requiring extensive resection and replacement; * severe trauma requiring extensive resection and replacement. The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The distal femoral component, the tibial components, and the non-porous coated straight and bowed stems are intended for cemented use only.

Source page: https://510kreport.com/device/K033959
Methodology: https://510kreport.com/methodology